Heterotaxy Syndrome and Intestinal Rotation Abnormalities - A Prospective Study

Heterotaxy Syndrome Clinical Trial

Official title:

Heterotaxy Syndrome and Intestinal Rotation Abnormalities - A Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01591928
• Other study ID #: 2012-LR-01
• Status: Completed
• Start date: March 2012
• Est. completion date: December 2016

Study information

• Verified date: December 2018
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Infants with heterotaxy syndrome (HS) are born with an abnormal arrangement of organs along the right-left body axis. Abnormalities of intestinal rotation and fixation are commonly associated with HS. Malrotation is the most worrisome intestinal rotation abnormality (IRA). Advances in cardiac surgery have improved HS mortality such that there is increasing attention to IRA and their management. The objective of this research project is to prospectively observe a cohort of infants with HS and IRA and evaluate their long term outcomes. Specifically, the investigators would like to determine what is the natural history of asymptomatic IRA in patients with HS and what is the morbidity and mortality secondary to an elective Ladd procedure for asymptomatic IRA in a population with HS? The investigators plan a prospective, multi-center, observational study to follow this complicated group of patients. This will be a web-based database collected from major cardiac tertiary care centers in both Canada and the United States. Patients with HS will be recruited by their primary site and clinical data will be collected by their primary site prospectively throughout childhood until they are at least five years of age. This patient population will be followed by their own clinical care givers; this is not an interventional study. No additional clinic visits will be required and the patients will not have to be contacted. Patient medical records will be accessed by a member of the study team at the primary site at least once per year or more frequently if interventions are required or complications develop.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

• All infants less than or equal to six months of age with a new diagnosis of heterotaxy syndrome

Exclusion Criteria:

Related Conditions & MeSH terms

• Heterotaxy Syndrome
• Syndrome

Locations

Country	Name	City	State
Canada	Stollery Children's Hospital	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Midgut volvulus	Surgical intervention	First year of life
Secondary	Morbidity secondary to a prophylactic Ladd procedure		Post Ladd procedure
Secondary	Mortality secondary to a prophylactic Ladd procedure		Within one month of Ladd procedure